Celiac Disease in ChildrenNCT06519916
Mental Perfomance in Patients With Coeliac Disease
An observational study of Celiac Disease in Children and Gluten Allergy, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial summary
Coeliac disease (CD) is an immune-mediated systemic disorder triggered by gluten in genetically predisposed patients. The only available treatment is a strict life long gluten-free diet (GFD), which has been linked to a reduced quality of life (QOL) and causes alterations in the gastrointestinal microbiome. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Celiac Disease in Children, Gluten Allergy
- What is being tested?
- Assessment of mental performance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 444 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with CD according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), were informed about the study. Further inclusion criteria were a strict adherence to the diet, defined as a negative transglutaminase for at least one year before participation in the study
Who may be able to join
- CD diagnosed according to European guidelines (ESPGHAN)
- only patients, who stick to a strict glutenfree diet (measured by transglutaminase for at least a year before participation in the study)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Gluten-free Diet Change the Mental Performance? A Comparative Study of Cognitive Function Among Children With Coeliac Disease and Healthy Controls
Coeliac disease (CD) is an immune-mediated systemic disorder triggered by gluten in genetically predisposed patients. The only available treatment is a strict life long gluten-free diet (GFD), which has been linked to a reduced quality of life (QOL) and causes alterations in the gastrointestinal microbiome. Abnormal compositions of the microbiome are now recognized as factors in the pathogenesis of neuropsychological disorders via gut-brain-axis. The aim of this study was to assess the QOL and the mental performance of children and teenagers with CD and compare it to healthy controls (HC).
Methods: Children between the ages of 6 and 18 years with CD and age-and-sex-matched healthy controls (HC) filled in a questionnaire to assess QOL and performed the Flanker task, a standardized test to assess cognitive performance.
Read the detailed description
Between July 2020 and August 2021, all children aged between 6 and 18 years, under the care of the University Children's hospital of Basel and the Children's hospital of Aarau, Switzerland, diagnosed with CD according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, were informed about the study. Further inclusion criteria were a strict adherence to the diet, defined as a negative transglutaminase for at least one year before participation in the study. Exclusion criteria comprised a diagnosis made less than a year ago, the presence of other chronic diseases, including food allergies, and the intake of regular medication. CD patients and their parents were informed about the study during the regular appointment for a clinical and serological check-up. After obtaining their consent, patients received another appointment to participate in the study.
For every CD-patient an age-and-sex-matched healthy control was recruited. Exclusion criteria for healthy controls were chronic diseases, regular medication intake, food allergies or specific diets.
Firstly, all participants were asked to fill in the questionnaire to examine the QOL. 'Kidscreen52' was used, a standardized questionnaire containing 52 questions, developed to assess the subjective health and the psychological, mental, and social well-being of children and adolescents covering ten important aspects of life (physical well-being, psychological well-being, moods \& emotions, self-perception, autonomy, parent relation \& home life, financial resources, peers \& social support, school environment, bullying). The answers to all questions were converted into numbers from one to five. In most subgroups, a higher number indicates a more positive answer, except for 'self-perception' (questions are like: 'do you doubt your appearance' etc.) and 'bullying', where a lower number indicates also less exposure to bullying. Participants were also asked to fill in the ISI (insomnia severety index), a 7-item self-report standardized questionnaire assessing the nature, severity, and impact of insomnia.
Participants completed a computerized Flanker task to assess cognitive performance. In this cognitive task, the target was flanked by non-target stimuli, which correspond either to the same directional response as the target (congruent flankers) or to the opposite response (incongruent flankers). In our child-friendly variant, participants were presented with five fish in a row and were asked to press the correct button according to the orientation of the target (central fish). Participants were instructed to respond as accurately and as quickly as possible. The two different conditions were presented with equal probability. Visual stimuli were shown for 200 ms against a black background, followed by a blank inter-trial period of random length between 900 and 1300 ms. Participants completed one practice block and two test blocks with 40 trials each. Flanker task is a reliable, well-recognized neuropsychological test for assessing executive function . Mean reaction times (on response-correct trials) and accuracy rates were calculated for congruent and incongruent trials.
To have consistency, the interviews and instructions for Flanker task were conducted by the same three students. Uncomplete patient data sets were excluded.
- Conditions
- Celiac Disease in Children, Gluten Allergy
- Being tested
- Assessment of mental performance
- Keywords
- mental performance, gluten-free diet, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of mental performanceBehavioural
There was no intervention, the mental performance was assessed
| Study group | Role | What they receive |
|---|---|---|
| Patients with CD | Patients with CD, who have been diagnosed according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and stick strictly to a gluten-free diet (transglutaminase negative, at least for a year) Receives: Behavioral: Assessment of mental performance | |
| Healthy control group | Age-and-sex-matched healthy control. Exclusion criteria for healthy controls were chronic diseases, regular medication intake, food allergies or specific diets. Receives: Behavioral: Assessment of mental performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental performance
The performance of the Flanker -Test was compared. Flanker-Test is a standardised test to assess mental performance. All participants performed this Flanker-Test (Computer Test) and afterwards the quality of life (see below ) was assessed. There was no follow-up, in this study participants with Coeliac disease and healthy controls only performed the Flanker-Test and the assessment of Quality of life (qol)and both groups were compared to each other. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day.
Measured: cross-sectional
Secondary outcomes (1)
Quality of life (qol)
The outcome of qol was compared. To assess the quality of life, all participants had to fill in the questionnaire (Kidscreen-52) at the same time, than the Flanker-Test. All tests were performed within one year. Both tests were compared between the patients with Coeliac disease and the healthy control group. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day.
For the qol, the higher the score, the higher the qol
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jul 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Legeret, Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519916
- Sponsor's protocol ID
- 2019-01095
- Other IDs
- 2019
- Status last verified
- Jul 2024
- First submitted
- 28 May 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Gluten-free Diet Change the Mental Performance? A Comparative Study of Cognitive Function Among Children With Coeliac Disease and Healthy Controls
- ClinicalTrials.gov ID
- NCT06519916
- Acronym / sponsor ID
- 2019-01095
- Conditions
- Celiac Disease in Children, Gluten Allergy
- Keywords
- mental performance, gluten-free diet, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coeliac disease (CD) is an immune-mediated systemic disorder triggered by gluten in genetically predisposed patients. The only available treatment is a strict life long gluten-free diet (GFD), which has been linked to a reduced quality of life (QOL) and causes alterations in the gastrointestinal microbiome. Abnormal compositions of the microbiome are now recognized as factors in the pathogenesis of neuropsychological disorders via gut-brain-axis. The aim of this study was to assess the QOL and the mental performance of children and teenagers with CD and compare it to healthy controls (HC).
Methods: Children between the ages of 6 and 18 years with CD and age-and-sex-matched healthy controls (HC) filled in a questionnaire to assess QOL and performed the Flanker task, a standardized test to assess cognitive performance.
Detailed description
Between July 2020 and August 2021, all children aged between 6 and 18 years, under the care of the University Children's hospital of Basel and the Children's hospital of Aarau, Switzerland, diagnosed with CD according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, were informed about the study. Further inclusion criteria were a strict adherence to the diet, defined as a negative transglutaminase for at least one year before participation in the study. Exclusion criteria comprised a diagnosis made less than a year ago, the presence of other chronic diseases, including food allergies, and the intake of regular medication. CD patients and their parents were informed about the study during the regular appointment for a clinical and serological check-up. After obtaining their consent, patients received another appointment to participate in the study.
For every CD-patient an age-and-sex-matched healthy control was recruited. Exclusion criteria for healthy controls were chronic diseases, regular medication intake, food allergies or specific diets.
Firstly, all participants were asked to fill in the questionnaire to examine the QOL. 'Kidscreen52' was used, a standardized questionnaire containing 52 questions, developed to assess the subjective health and the psychological, mental, and social well-being of children and adolescents covering ten important aspects of life (physical well-being, psychological well-being, moods \& emotions, self-perception, autonomy, parent relation \& home life, financial resources, peers \& social support, school environment, bullying). The answers to all questions were converted into numbers from one to five. In most subgroups, a higher number indicates a more positive answer, except for 'self-perception' (questions are like: 'do you doubt your appearance' etc.) and 'bullying', where a lower number indicates also less exposure to bullying. Participants were also asked to fill in the ISI (insomnia severety index), a 7-item self-report standardized questionnaire assessing the nature, severity, and impact of insomnia.
Participants completed a computerized Flanker task to assess cognitive performance. In this cognitive task, the target was flanked by non-target stimuli, which correspond either to the same directional response as the target (congruent flankers) or to the opposite response (incongruent flankers). In our child-friendly variant, participants were presented with five fish in a row and were asked to press the correct button according to the orientation of the target (central fish). Participants were instructed to respond as accurately and as quickly as possible. The two different conditions were presented with equal probability. Visual stimuli were shown for 200 ms against a black background, followed by a blank inter-trial period of random length between 900 and 1300 ms. Participants completed one practice block and two test blocks with 40 trials each. Flanker task is a reliable, well-recognized neuropsychological test for assessing executive function . Mean reaction times (on response-correct trials) and accuracy rates were calculated for congruent and incongruent trials.
To have consistency, the interviews and instructions for Flanker task were conducted by the same three students. Uncomplete patient data sets were excluded.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CD | – | Behavioral: Assessment of mental performancePatients with CD, who have been diagnosed according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and stick strictly to a gluten-free diet (transglutaminase negative, at least for a year) |
| Healthy control group | – | Behavioral: Assessment of mental performanceAge-and-sex-matched healthy control. Exclusion criteria for healthy controls were chronic diseases, regular medication intake, food allergies or specific diets. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with CD according to the Guidelines for diagnosing CD of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), were informed about the study. Further inclusion criteria were a strict adherence to the diet, defined as a negative transglutaminase for at least one year before participation in the study
Key inclusion criteria (2 listed)
- CD diagnosed according to European guidelines (ESPGHAN)
- only patients, who stick to a strict glutenfree diet (measured by transglutaminase for at least a year before participation in the study)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of mental performanceThere was no intervention, the mental performance was assessed | Behavioural | Healthy control group, Patients with CD |
Primary outcome
Mental performance
Time frame: cross-sectional
The performance of the Flanker -Test was compared. Flanker-Test is a standardised test to assess mental performance. All participants performed this Flanker-Test (Computer Test) and afterwards the quality of life (see below ) was assessed. There was no follow-up, in this study participants with Coeliac disease and healthy controls only performed the Flanker-Test and the assessment of Quality of life (qol)and both groups were compared to each other. In other words, it is a snapshot, as the Flanker test and the quality of life survey were carried out on the same day.
1 secondary outcome
Quality of life (qol)
Time frame: cross-sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Legeret principal investigator
University Children's Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children and Gluten Allergy, run by University Children's Hospital Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental performance (time frame: cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.